Pen needle packaging

ABSTRACT

A disposable pen needle, comprising a hub having a needle situated thereon having a patient end and a non-patient end, a removable patient end cap attached at the distal end of the hub, a removable non-patient end cap attached at the proximal end of the hub, wherein greater force is required to detach the patient end cap than is required to detach the non-patient end cap.

This application is a division of U.S. Nonprovisional application Ser.No. 14/655,712, filed Jun. 25, 2015, which is a national stageapplication, filed under 35 U.S.C. § 371, of International ApplicationNo. PCT/US2013/077699, filed Dec. 24, 2013 which claims the benefitunder 35 U.S.C. § 119(e) of U.S. Provisional Application No. 61/746,104,filed Dec. 26, 2012, No. 61/746,105, filed Dec. 26, 2012, No.61/746,102, filed Dec. 26, 2012 and No. 61/751,333, filed Jan. 11, 2013,all of which are incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The invention is in the field of sterile packaging for a pen needle. Inparticular, the disclosure pertains to sterile containers for a penneedle which can be opened by the user with one hand, without removing aheat sealed paper-foil label, and/or manipulated to install the penneedle on a medication pen without separately handling the pen needle.In embodiments, the packaging serves as a sharps container after use.

Description of the Related Art

Pen needles are widely used in medication delivery systems forself-administered injectable drugs. The pen needle is a separate unitfrom the medication pen which contains the medication and it istransported and sold in sterile packaging. In the packaging commonlyused, the pen needle is shielded with an “inner shield” covering theneedle. The needle-bearing hub and the inner shield are then packagedinto an “outer shield” which contains the pen needle. A paper-foil peeloff label (sometimes referred to as a “teardrop label”) provides sterileclosure to the container. Although such containers are widely used, itis desirable to simplify the packaging and improve the product in termsof ease of use, so that it can be opened with one hand, for example, andwithout handling the pen needle prior to installing the pen needle on amedication pen.

United States Patent Application Publication No. 2012/0016300 describesa pen needle assembly having a hub with a needle thereon which isreceived in an outer cover. The cover is provided with a locking memberfor locking the needle in the outer cover. In embodiments, the needle issecured in the outer cover with a cap, attached to the hub by a hinge.

U.S. Pat. No. 8,133,200 describes a reversible cap for a pen needlewhich connects to an outer cover of the pen needle in a first positionbefore the needle is used and in a second position after the needle isused. In embodiments, the cap is removable in the first position andlocked to the outer cover in the second position.

International Application No. WO 2010/090734 describes a pen needleassembly, comprising a hub with a needle fixed thereon; a cover membercovering a first end of the needle; and a sealing member for covering asecond end of the needle. One or more of the hub, cover member and thesealing member are made of a biodegradable material. Although closuresare provided on opposite ends of the pen needle, sterility is maintainedusing an “inner shield” over the patient end of the needle in thepackaging.

Notwithstanding the improvements described in the aforesaid related art,it is still desirable to improve the known pen needle assemblies andsterile packaging, in terms of amount of materials used and ease of use.

SUMMARY OF THE INVENTION

In one aspect, these objects are achieved according to the inventionwith a pen needle container receiving the patient end and non-patientend of the pen needle in a specified orientation. The containercomprises: a first chamber having walls, a closed end, and an openinghaving edges defining a plane which is aligned with the non-patient endof a pen needle received in the container. A rigid closure attached toand movable with respect to the chamber has a planar member whichcompletely closes off the open end of the chamber in a first position.Attachment means are provided for attaching the closure to the chamberand repeatedly moving the closure from the first position to a secondposition in which the opening is unobstructed by the closure. Asterility barrier ensuring sterility of the chamber in the firstposition is broken when the closure is first moved from the firstposition to the second position. In embodiments, the chamber walls areat 90 degree angles to form a rectangular box. In preferred embodiments,the pen needle is simply a needle-bearing hub adapted for attachment toa medication pen, because the container and closure perform thefunctions of the outer cover, the inner shield, and the heat-sealedlabel of a conventional pen needle.

In another aspect of the invention, the attachment means is a hingeformed along an edge of the container perpendicular to the edgesdefining the opening. In other embodiments, the container is formed likea drawer, so that the attachment means comprises a pair of groovesformed along opposite interior walls of the chamber, cooperating withpins protruding from lateral sides of the closure. The closure may thenbe swiveled about the pins to provide an unobstructed opening to thechamber.

In another aspect of the invention, the pen needle packaging conceptcomprises a hub having a needle situated thereon having a patient endand a non-patient end. A cap connected to the hub is formed of first andsecond ears attached with a hinge. In the closed position of the hinge,the cap encloses both ends of the needle in a sterile enclosure. In theopen position of the hinge, the ears of the cap are pressed together bythe user, the package is opened, and the non-patient end of the penneedle is exposed. Pressing the halves together to open the hinge maybreak a sterile barrier, which may be a tortuous path sterile barrier oralternatively an externally applied seal. The user may remove the cap bypulling on the cap after the pen needle is installed on the medicationpen.

In embodiments according to this aspect of the invention, the pen needlecomprises an inner shield surrounding the patient end of the needle. Aprotrusion on the interior of the cap mates with a feature formed on theinner shield to stably orient the hub when the cap is pinched open. Theinner shield is in turn surrounded by the cap in the closed position andmay be disposed so that it is removed with the cap after installation ofthe pen needle on the medication pen.

Alternatively, the hub may be received with an interference fit in oneor the other of the hinged halves of the cap, so that the needle-bearinghub is presented to the user for installation on a medication pen whenthe packaging is opened.

In another aspect, the pen needle packaging concept is embodied byhaving caps on opposed ends of the hub which may be held by the userwhen the pen needle is opened for use. The caps can be mated with theopposed sides of the hub or with each other. The caps can be configuredto detach from the hub (or from each other) in a particular order toenhance ease-of-use, such that the non-patient end cap is always removedfirst. For example, greater force is required to detach the patient endcap from the hub (or from the opposed non-patient end cap) than isrequired to detach the non-patient end cap from the hub (or the opposedpatient end cap). The caps are configured so that the user can hold thepen needle by the patient end cap while removing the non-patient end capto install the pen needle on a medication pen. The caps may be mated,with a tortuous path barrier for example, to form a sterile enclosurearound the needle with a single sterile barrier. In other embodiments ofthe invention, the patient end cap and the non-patient end cap may formseparate sterile enclosures around the patient end needle andnon-patient end needle, respectively.

Increasing the force required to detach one cap relative to the forcerequired to detach the other may be accomplished by means known in theart, including without limitation, heat or laser staking, providingdifferent size interference fits, using mechanical snaps or beads,threads, friction welding, using adhesives, or with breakable plasticwebs, as described in greater detail below.

In an embodiment according to this aspect of the invention, a disposablepen needle comprises: a hub having a needle situated thereon having apatient end and a non-patient end. A removable patient end cap isattached to the distal end of the hub and a removable non-patient endcap is attached to the proximal end of the hub, overlapping the proximalend of the patient end cap in a single continuous seam, thus forming asingle sterile enclosure around the needle.

The pen needle may be provided with one or more tethers connecting thenon-patient end cap and the patient end cap to the hub after the seambetween the non-patient end cap and the patient end cap has been brokenand the respective caps have been detached from one another.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic view of a pen needle container according to anembodiment of the invention.

FIG. 1B is a view of the embodiment of FIG. 1A in an open position.

FIG. 1C is a view of the embodiment of FIG. 1A rotated to depict theview into the open end of the container, with the pen needle aligned tothe opening.

FIG. 2A is a schematic view of an embodiment of the invention in whichmultiple chambers are combined in a container system.

FIG. 2B depicts the embodiment of FIG. 2A in the open position.

FIG. 3A depicts a re-use prevention mechanism according to an embodimentof the invention in a first position.

FIG. 3B depicts the re-use prevention mechanism in a second position.

FIG. 4A depicts a top view of a drawer-style embodiment of the penneedle packaging concept according to the invention.

FIG. 4B depicts a side view of the embodiment of FIG. 4A.

FIG. 4C depicts the container packaging embodiment of FIG. 4A and FIG.4B in the open position.

FIG. 5A depicts another embodiment of the invention in the closedposition.

FIG. 5B depicts the embodiment of FIG. 5A in an open position.

FIG. 6A depicts another embodiment of the invention in the closedposition.

FIG. 6B depicts the embodiment of FIG. 6A in an open position.

FIG. 7A is a top view of another embodiment according to the invention.

FIG. 7B depicts a side view of the embodiment of FIG. 7A.

FIG. 8A depicts a sterile closure system according to an embodiment ofthe invention.

FIG. 8B depicts the embodiment of FIG. 8A in the fully open position.

FIG. 8C depicts a sterile closure system according to another embodimentof the invention.

FIG. 8D depicts the embodiment of FIG. 8C as the sterile closure isopened.

FIG. 9 is a cross sectional view of pen needle packaging according to anembodiment of the invention in the closed state.

FIG. 10 depicts the outside of the pen needle packaging according to theembodiment of FIG. 9.

FIG. 11 depicts the pen needle packaging according to FIG. 9 in the openstate.

FIG. 12 depicts a pen needle with mating caps according to an embodimentof the invention in a sealed state.

FIG. 13 is an exploded view of the pen needle of FIG. 12.

FIG. 14 is a detail depicting the engagement of the patient end cap andthe hub.

FIG. 15 depicts an alternative embodiment with a threaded engagement ofthe caps.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, a “pen needle” according to the invention may consist ofonly a needle-bearing hub, because the packaging substitutes for theconventional outer cover and tear drop label. The pen needle has a“non-patient” end which is adapted to be attached to a medication pen.When received in the container, the pen needle hub is situated so thatthe non-patient end is at the opening of the container for easy accessby the user, substantially in the plane of the opening. As used herein,the edges which define the opening are said to be “aligned” with thenon-patient end of the pen needle in this state. As used herein, theopening to the pen needle chamber is “unobstructed” when the edgesdefining the opening are free of hinges or any other elements thatimpede access to the pen needle. “Removable,” as used herein, means thata part is intended to be removed by a user during normal use of thedevice.

In various embodiments the container is in the shape of a box. Thesidewalls of the box are said to be at a “90 degree angle,”notwithstanding that plastic molding processes may require the cornersto be rounded. Likewise, sidewalls of the box meet at “edges,” such thatthree edges of a box meet at a corner. These need not be sharp edges tobe considered edges, provided the overall appearance creates animpression of a rectangular box. Terms such as “inward,” “inner,” and“inside” mean toward or facing the inside of the container, and“outward,” “outer” and “outside” have the opposite meaning. The drawingsare schematic and not to scale.

The embodiments of the invention described herein are intended to reducethe steps necessary for the user to retrieve a pen needle from itspackaging and install it on a medication pen. In the embodimentsdescribed herein, a peel-off label closing off an open end of thepackaging can be omitted. Instead, opening the container to access thepen needle breaks the sterile barrier. In many cases, the embodimentsdescribed below are capable of one-handed operation, so that the userneed not handle the pen needle excessively before installing it on themedication pen. The secure packaging makes it possible in many cases toavoid use of the inner shield used in current packaging. The containeritself may act as both a shield and as a sharps container after use.

In one embodiment of the invention, depicted in schematic cross sectionin FIG. 1A, the pen needle container 10 includes a first chamber 12 inthe shape of a rectangular box or cuboid. An internal space 16 forreceiving the pen needle is oriented so that the patient end is towardthe closed end 14 of the container. Opposite the closed end is an openend 18 which is completely closed off by closure 20 in an initial state.The closure is sealed to the container with a sterile barrier (not shownin FIG. 1). The shape of the internal space 16 in the container mirrorsthe shape of the pen needle, so that the pen needle is stowed securely.

FIG. 1B depicts the embodiment of FIG. 1A in a second, open position. Asseen in FIG. 1B, closure 20 is L-shaped, having a first planar member 22which closes off the open end 18 of the chamber 12, and a second planarmember 24, attached to an edge of the first planar member. The secondplanar member 24 is attached by hinge 26 along an edge of the chamberperpendicular to the edges of the open end 18. Attaching the secondplanar member to the chamber and the first planar member 22 in this wayallows the closure to be manipulated easily by a user with one hand andalso allows the open end 18 of the chamber to be completely unobstructedin the open state. A sterile barrier may be applied on a seam formed bythe closure 20 and the open end 18 of the pen needle chamber. Thesterile barrier is broken when the packaging is opened, which may bedone one-handed, leaving no remnants of the barrier on the edges of theopen end of 18 of the chamber.

FIG. 1C depicts the chamber of the embodiment of FIG. 1A in crosssection in the second, open, position as seen from the open end 18 ofFIG. 1B. In this position, the pen needle hub 30 is exposed, includingthe non-patient end needle 17, so that the medication pen can beattached to the needle hub while the user holds the container.

Multiple containers similar to that shown in FIG. 1A may be attached, asshown in the embodiment of FIG. 2A and FIG. 2B, and the one-piece orunitary closure 20 completely closes off the open ends of the respectivechambers 12 in the first position. As with the embodiment of FIG. 1A,the action of opening the closure is a single handed operation whichbreaks a sterile barrier formed along the seam between the closure andthe open end of the container. The increased size of the assembledcontainers in the embodiment of FIG. 2A and FIG. 2B is expected to makethe container easy to manipulate.

FIG. 3A and FIG. 3B depict a re-use prevention mechanism which can beused with multiple embodiments according to the invention. In an initialposition, pen needle assembly 32 is stowed in internal space 16. Twotapered stops 31 having inclined surfaces sloped toward the inside ofthe container prevent the pen needle from moving in the internal space.After attachment to a medication pen, the pen needle may be slid out ofthe container by the user. To use the packaging as a sharps container,the user inserts the pen needle past the tapered stops 31, as shown inFIG. 3B, such that the pen needle cannot be easily removed by the user.The pen needle need not be handled by the user when installing themedication pen and the “inner shield” conventionally provided with a penneedle may be omitted.

In another embodiment, depicted in FIGS. 4A, 4B, and 4C, the pen needlepackaging according to the invention includes a drawer-style closurewhich is received in container 44. As with the previous embodiment, thecontainer is a rectangular box or cuboid. Closure 40 is L-shaped andincludes top member 46 and first planar member 48, which completelycloses off the open end 47 of the container when the container isclosed. The top view is shown in FIG. 4A, wherein the pen needle isaccessed by sliding the top member 46 along grooves 49 formed in theside walls of the container. The pen needle internal space 16 may besituated as shown in the side view of FIG. 4B, opposite the closed end43. The container 44 includes a closed end 43 and an open end 47opposite the closed end where internal space 16 for receiving the penneedle is situated. The non-patient end of the pen needle issubstantially flush with the plane defined by the edges of the open end47. The seam where the first planar member 48 meets the container 44 maybe sealed with a sterile barrier in the closed position. The top member46 of the L-shaped closure 40 is provided with pins 45 protruding fromopposite lateral sides thereof which are received in grooves 49 in theinner side walls of the container 44.

The side view of FIG. 4B depicts pins 45 received in grooves 49 formedin the inner side walls of the chamber 44. The grooves 49 terminate in aportion 52 wider than the rest of the groove. The wider portion 52permits the closure 40 to be rotated, pivoting about the wider portion52, so that the planar member 48 is rotated away from the opening 47 andthe opening is completely unobstructed in the open position, as shown inFIG. 4C.

In the specific embodiment shown, which is not to be deemed as limitingthe invention, the grooves 49 are parallel to the top edge of thechamber 44 where two walls of the chamber meet. In other embodiments,such as depicted in FIGS. 5A and 5B, 6A and 6B, 7A and 7B, and 8A and8B, the grooves 49 may be oriented diagonally on the side walls of thecontainer, or the grooves may have a bend, with a section parallel tothe edges of the box and a section oriented diagonally on the side ofthe box.

The closure may also be embodied as an outer shell or cover as shown inFIGS. 5A and 5B. In the embodiment of FIG. 5A, pins (not shown) protrudeinwardly, toward the chamber, from opposite lateral sides of cover 54.Cover 54 comprises a top surface 46 and side surfaces 53 perpendicularto the top surface, with the top and side surfaces all perpendicular tothe planar member 48 which closes off an opening for the pen needleinternal space 16. Grooves 49 are formed on the outer walls of thechambers 58, 59 to receive the pins, which allows the cover 54 to slidediagonally on the outside of the container.

Multiple chambers 58, 59 may be included in a single container, eachhaving an open end 56 with edges 57 defining a plane. Each chamber 58,59 includes an internal space 16 for securely receiving a pen needle, asshown in the side view of FIG. 5B. With this configuration, bothinternal spaces 16 where a pen needle is secured may be unobstructed bya closure without a pivoting arrangement of the cover 54, although thecover may be adapted to pivot as in the previously described embodiment,if desired.

In yet another alternative embodiment, as shown in FIG. 6A and FIG. 6B,the diagonal groove extends partially along the outer sidewall of thecontainer, and the cover is provided with the ability to pivot about apoint in the middle of the container side wall. As shown in FIG. 6B,this arrangement allows the closure to be manipulated so that theopening(s) of the container are unobstructed by the closure.

For ease of use, in several of the drawer-style embodiments of thepackaging according to the invention, a textured portion 42 is providedon the lid, which the user may manipulate with a thumb or other fingerto facilitate one handed opening. Textured portion 42 may be usedadvantageously with any of the closure systems having a sliding top.Likewise, the tapered stops described in connection with FIG. 3A andFIG. 3B, and shown in FIG. 5A and FIG. 5B may be used with anyembodiment of the invention described herein so that the container maybe used to safely store the pen needle after use. In FIG. 7A and FIG. 7Ban additional member 82 on the closure is depicted which provides a gripfor the users' fingers to push against when opening the container, inaddition to, or as an alternative to, the textured portion 42.

Sterility of the cannula may be maintained by presenting a tortuous pathto airborne microorganisms between the outside of the container and thepen needle space 16. For example, in FIGS. 8A and 8B, sterility can bemaintained by providing matching tortuous path faces on the cover 40 andthe chamber 58. In FIG. 8A and FIG. 8B a pair of mating features, suchas ring 84 and receiving recess 86 provide the necessary tortuous path.A straight portion of the groove on the side of the container permitsthe mating features 84, 86 to detach when the container is initiallyopened and before the pivoting motion begins.

FIG. 8C and FIG. 8D depict an alternative sterility barrier in which afilm barrier is sealed across the open end of the pen needle chamber 16.The film 92 is attached the planar member 48 of the closure. When theplanar member 48 is pivoted away from the open end of the chamber, thefilm 92 is peeled automatically from the opening. In this manner, thesingle act of opening the container performs the functions of removingthe sterility barrier and allowing access to the pen needle via anunobstructed opening. As with the previous embodiments, a separate stepof peeling a label to provide access to the pen needle is omitted.

In another aspect, the invention pertains to pen needle packaging whichpermits the user to squeeze one end of the pen needle packaging on thepatient-end side of the assembly, which in turn breaks open the oppositeend of the packaging to expose the non-patient end of the pen needle forattachment to a medication pen.

In the cross-sectional view of FIG. 9, pen needle hub 30 has a needle 90situated thereon having a patient end 132 and a non-patient end 134.Opening 124 on the non-patient end of the hub is provided with threads220 for installation of the pen needle on a medication pen. Cap 100 isformed of first and second ears 110, 120 attached with a hinge 50. Theears 110, 120 constitute halves of the closed cap structure. Hinge maybe of any type, such as a “living hinge,” or coiled flexible strip asshown in FIG. 11. First and second ears 110, 120 may be provided withtextured surfaces 16, which the user can grasp to pinch the earstogether to provide more ergonomic packaging. The hinge is shown in theclosed position in FIG. 9 and FIG. 10, with the patient end and thenon-patient end of the needle enclosed in a sterile enclosure. It ispreferable that the end of the cap with the ears extends from the distalside of the hub, beyond the patient end of the needle.

Sterility may be maintained by a providing a tortuous path for theclosure of ears 110, 120, such as step shapes on the respective earsthat engage when the ears are closed to present a tortuous path thatprevents airborne microorganisms from entering the sterile space aroundpatient end needle 132. Alternatively, a label over the seam between thetwo halves may be used to form a sterile barrier. In either case, theears are adapted to open along seam 18, shown in FIG. 10, andpreferably, the halves are burst open by the user pinching the ears. Forthis purpose, the seam 18 may be nearly perforated, but not punchedthrough, so that the packaging can be burst open, but sterility ismaintained. If desired, the halves of the cap may be provided withmating elements so that the cap can be locked shut after use. In thisway, the cap according to the invention can be used as a sharpscontainer.

This packaging concept has the advantage of reducing the number of stepsrequired to access and use the pen needle. Rather than having to removea teardrop label, as in existing commercial embodiments, theconfiguration according to the invention can be opened with one hand bysqueezing one end of the cover. After opening, the open end 124 of thepen needle is accessible for attachment to the medication pen. In FIG.11, the pen needle is cradled in one of the halves in an interferencefit when the cap is pinched apart. In another embodiment (not shown), aremovable inner shield is fitted over the patient end of the needlearound post 93 on the hub. The inner shield can contact a featureprovided on the cap to retain the needle bearing hub in a centralposition using the post 93 on the hub.

The flexible front end cap has other advantages over the conventionalpen needle sealed with tear drop label, in that similarly shapedpackaging units may be nested. Thus, the space between ears 110, 120 mayreceive the non-patient end of another cap, so that a series of similarcaps can be provided in a dispenser, for example.

In another aspect of the invention, the pen needle packaging isconfigured to be gripped by the user and opened so that the non-patientclosure breaks away first, exposing the non-patient side of the penneedle for installation on a medication pen. In the embodiment depictedin FIG. 12, the pen needle is provided with outer caps that seal to thepen needle hub, or to each other, to provide a sterile enclosure aroundthe pen needle. Sterility can be maintained using a tortuous path formedby the overlapping of the caps, and/or a barrier label can be formedover the seam between the caps. The mating of the caps can be configuredso that the non-patient end of the hub is presented to the user readyfor installation on a medication pen when the sterility barrier isbroken. The concept of a tortuous path or labyrinth seal to preservesterility is well known in the biomedical devices art, and simply meansthat airborne organisms are presented with a tortuous path whichprevents the organisms from contaminating the enclosed space around thecannula. In the closure described above, the barrier forms a type ofseal which must be broken by the user before use, but the force requiredis not so great as to cause inconvenience. The concept of the labyrinthseal is elaborated upon in U.S. Patent Application Publication No.2012/0041381, incorporated by reference.

In the exploded view of FIG. 13, patient end cap 201 is shown fittingover the needle cannula on the patient side of the hub 30, andnon-patient end cap 401 fits over the non-patient side of the hub. Inthe conventional designs, the entire hub is inserted into a single cap,and the open end of the cap is closed off with a sterile tear droplabel. Typically, an inner shield is positioned between the needlecannula and the cap. The shorter patient end cap of the presentembodiment eliminates the tear drop label and the conventional innershield and reduces overall material usage.

To improve ease-of-use, patient end cap 201 may be provided with atextured surface 221 for the user to grasp. Referring to FIG. 15, a gripin the form of wings 460 may be provided on the non-patient end cap toimprove ergonomics. The use of the textured surface or shapednon-patient end cap is not limited to the embodiment of FIG. 12 throughFIG. 15.

In another embodiment, the non-patient end cap and the patient end capeach form a separate sterile barrier around the respective needles. Toensure that the non-patient end cap is detached first, the patient endcap may be attached to the hub using staking, whereby a protrusion onthe hub or cap is mated with a corresponding dimple in the other elementand then the dimple is conformed around the protrusion using heat orlaser. An attachment means requiring less force, such as a slightinterference fit may be provided between the hub and the non-patient endcap on the proximal end of the hub. Many other means are available toensure that a greater force is required to detach the patient end capfrom the hub relative to the non-patient end cap. For example, the capon the patient end side may be attached with threading. Staking can beapplied to the attachment of the caps on both sides of the hub, providedthat the patient end side is staked more securely. Likewise, differentinterference fits can be employed on both sides of the hub. The forcedorder of opening the cap ensures that the user handles the patient-endof the pen needle by its outer cap during installation and reduces thelikelihood of accidental needle sticks.

FIG. 14 depicts another example in which the caps are configured so thatthe non-patient end cap 40 pulls away first from the hub 30 when thecaps are separated. For this purpose one or more protrusions 260 on thehub mates with a corresponding feature on the inside of the patient endcap 201. Consequently, a slightly increased force is required toseparate the patient end cap from the hub, while the non-patient end cap420 is mated with the patient end cap 201 with an interference fit.Thus, during use, the non-patient end cap is removed first, allowing auser to expose the threads on the hub for installation on a medicationpen before the patient end cap is removed to expose the patient endcannula. This feature further obviates the need for a shield inside thepatient end cap—reducing the number of accidental needle sticks whileenhancing ease-of-use.

Sterility of the enclosure formed by the mated caps may be maintained byproviding a tortuous path where cap 420 meets the patient end cap at thesingle continuous seam between the two caps, as shown in FIG. 14.Alternatively, a label is used over the single seam to preservestability. According to another embodiment depicted in FIG. 15, thepatient end and non-patient end caps are mated via a threaded connection440, which also serves as a tortuous path sterility barrier.

The same container may be configured so that the hub can be recapped andthe two opposed caps 201 and 401 can be locked. Thus the mated caps actas a sharps container after use. The locking of the caps can be achievedin a variety of ways known in the art, such as by providing a fingerinside one of the caps and a corresponding groove on the other whichtraps the finger. The user rotates the caps relative to one another toalign the finger with the groove. So called “irreversible” interlockingarrangements in a similar context are known in the art. A lockingenclosure has the advantage that the user can determine when the deviceis to be permanently locked, which in some instances is preferred to anautomated lock-out achieved with a passively shielded pen needle.

Any material or method known in the art may be used to manufacture thehub and caps. Plastic injection molding is the presently preferredmethod. Using a molding technique, the caps may be formed with a tether,a strip of material connecting each cap to the hub. With this embodiment(not shown in the FIGS), the two caps may be formed as a single moldedpart. Left on the product, the tethers reduce the chance that a userloses a cap during use. Alternatively, the tethers may be cleaved fromthe product during assembly.

The above description of the preferred embodiments is not to be deemedlimiting of the invention, which is defined by the following claims. Theforegoing description should provide the artisan of ordinary skill withsufficient information to practice variants of the embodimentsdescribed. Features and improvements described in connection with oneembodiment or with one independent claim may be combined with otherembodiments or another independent claim without departing from thescope of the invention described.

1. A disposable pen needle, comprising: a hub having a needle situatedthereon having a patient end and a non-patient end; a removable patientend cap attached at the distal end of the hub; a removable non-patientend cap attached at the proximal end of the hub; wherein greater forceis required to detach the patient end cap than is required to detach thenon-patient end cap.
 2. The disposable pen needle according to claim 1,further comprising a single continuous seam between the patient end capand the non-patient end cap forming a sterile enclosure around theneedle.
 3. The disposable pen needle according to claim 2, wherein thecontinuous seam creates a tortuous path barrier forming a sterileenclosure around the needle.
 4. The disposable pen needle according toclaim 2, wherein a label is disposed over the single continuous seam topreserve stability.
 5. The disposable pen needle according to claim 1,wherein the patient end and non-patient end caps are mated via athreaded connection, which creates as a tortuous path sterility barrier.6. The disposable pen needle according to claim 1, wherein thenon-patient end cap and the patient end cap each form a separate sterileenclosure around the non-patient end needle and patient end needle,respectively, on opposite sides of the hub.
 7. The disposable pen needleaccording to claim 1, wherein the non-patient end cap and/or the patientend cap is attached to the hub by at least one means selected from heatstaking, threaded connection, breakable plastic webs, interference fit,adhesive, and friction welding.
 8. The disposable pen needle accordingto claim 1, further comprising: an interference fit between the hub andthe non-patient end cap; and mating protrusions on the inside of thepatient end cap and the outside of the hub engaging the hub andresulting in increased force required to separate the hub from thepatient end cover relative to the force required to separate the hubfrom the non-patient end cover.
 9. The disposable pen needle accordingto claim 1, further comprising tethers connecting the non-patient endcap and the patient end cap to the hub after the seam between thenon-patient end cap and the patient end cap is broken and the respectivecaps are detached from one another.
 10. The disposable pen needleaccording to claim 1, comprising a threaded mating connection betweenthe patient end cap and the non-patient end cap.
 11. The disposable penneedle according to claim 1, wherein the patient end cap and thenon-patient end cap are configured to lock together to enclose the hubafter use.
 12. The disposable pen needle according to claim 11, whereinthe patient end cap and the non-patient end cap are configured to bepermanently locked upon engagement.
 13. The disposable pen needleaccording to claim 1, wherein a tear drop label and an inner shield arenot present.
 14. A disposable pen needle packaging, comprising: a hubhaving a needle situated thereon having a patient end and a non-patientend; a cap formed of first and second ears attached with a hinge; thehinge having a closed position in which the patient end and thenon-patient end of the needle are enclosed in a sterile enclosure and anopen position in which the ears of the cap are pressed together and thenon-patient end of the needle is exposed.
 15. The disposable pen needlepackaging according to claim 14, further comprising: an inner shieldsurrounding the patient end of the needle; a protrusion on the inside ofthe cap mating with a feature formed on the inner shield to stablyorient the hub in the cap between the two halves when the cap is in theopen position.
 16. The disposable pen needle packaging according toclaim 14, wherein the first and second ears form a nesting shape whenthe hinge is in the closed position so that the non-patient end of asimilar pen needle packaging mates with the nesting shape.
 17. Thedisposable pen needle packaging according to claim 14, wherein the earsof the cap are provided with mating elements so that the cap can belocked shut after use with a used patient end needle secured therein.18. A method of packaging and using a pen needle, comprising: enclosinga pen needle in a sterile package comprising two rigid portions; openingthe sterile package by separating the rigid portions; removing the penneedle from the sterile package; and using the pen needle to perform aninjection.
 19. The method of claim 18, wherein the pen needle comprisesthe disposable pen needle of claim
 1. 20. The method of claim 18,wherein the sterile package comprises the disposable pen needlepackaging of claim 14.